Epitol

Epitol treats trigeminal neuralgia (a condition that causes facial nerve pain). Can interact with many medications. Tell your doctor about all of the medicines you take.

Epitol Overview

Updated: April 30, 2015

Carbamazepine is a prescription medication used to treat epilepsy and trigeminal neuralgia (a condition that causes facial nerve pain). Carbamazepine belongs to a group of drugs called anticonvulsants, which work by decreasing abnormal electrical activities in the brain that cause seizures. It also works by blocking nerve signals that cause pain in trigeminal neuralgia.

Carbamazepine comes in the form of an immediate-release tablet, an extended-release tablet, extended-release capsules, a chewable immediate-release tablet, and an oral suspension form. Carbamazepine may be taken 2 to 4 times daily, with or without food.

Common side effects of carbamazepine include dizziness, drowsiness, nausea, and vomiting. Do not drive or operate heavy machinery until you know how carbamazepine will affect you.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Epitol Precautions

1. Rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking carbamazepine within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take carbamazepine to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:

skin rash

hives

sores in your mouth

blistering or peeling of the skin

2. Rare but serious blood problems. Symptoms may include:

fever, sore throat or other infections that come and go or do not go away

easy bruising

red or purple spots on your body

bleeding gums or nose bleeds

severe fatigue or weakness

3. Like other antiepileptic drugs, carbamazepine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Carbamazepine may cause other serious side effects. These include:Irregular heartbeat - symptoms include:

Fast, slow, or pounding heartbeat

Shortness of breath

Feeling lightheaded

Fainting

Liver problems - symptoms include:

yellowing of your skin or the whites of your eyes

dark urine

pain on the right side of your stomach area (abdominal pain)

easy bruising

loss of appetite

nausea or vomiting

Get medical help right away if you have any of the symtoms listed above.

Do not take carbamazepine if you:

have a history of bone marrow depression.

are allergic to carbamazepine or any of the ingredients in carbamazepine.

take nefazodone.

are allergic to medicines called tricyclic antidepressants (TCAs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

have taken a medicine called a Monoamine Oxidase Inhibitor (MAOI) in the last 14 days. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking carbamazepine until you talk to your healthcare provider. Carbamazepine taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how carbamazepineaffects you. Carbamazepinemay slow your thinking and motor skills.

Epitol and Pregnancy

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Category D medicines have been shown to present a risk to the fetus in studies of pregnant women, but may be given to a pregnant woman the benefits to the woman outweigh the possible risks to the unborn child.

Epitol and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. Carbamazepine is excreted in human breast milk. You and your doctor should discuss whether you should take carbamazepine or breastfeed; you should not do both.

Epitol Usage

Carbamazepine comes in the form of an immediate-release tablet, an extended-release tablet, extended-release capsules, a chewable immediate-release tablet, and an oral suspension form. Carbamazepine may be taken 2 to 4 times daily, with or without food.

Take carbamazepine exactly as prescribed. Your healthcare provider will tell you how much carbamazepine to take.

Do not stop taking carbamazepine without first talking to your healthcare provider. Stopping carbamazepine suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).

Your healthcare provider may change your dose. Do not change your dose of carbamazepine without talking to your healthcare provider.

Take carbamazepine with food.

Extended-release tablets and capsules:

Do not crush, chew, or break.

Tell you healthcare provider if you can not swallow the extended-release tablets whole

Carbamazepine Suspension:

Shake the bottle well each time before use.

Do not take carbamazepine suspension at the same time you take other liquid medicines.

If you take too much carbamazepine, call your healthcare provider or local Poison Control Center right away.

Epitol FDA Warning

SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH Carbamazepine.

THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE.

HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH Carbamazepine.

PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH Carbamazepine UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK.

APLASTIC ANEMIA AND AGRANULOCYTOSIS

APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF Carbamazepine. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5-8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA.

ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF Carbamazepine, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.

BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON Carbamazepine ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY. DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT BONE MARROW DEPRESSION DEVELOPS.

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